DR NELSON: Access to pills is a real issue—it’s more than having to go to the pharmacy every few weeks. A recent paper from the California Family PACT (Planning, Access, Care and Treatment) Program showed that women who were dispensed a year’s supply of OCs at their first visit were more likely to continue therapy, were more likely to receive Papanicolaou tests and Chlamydia tests, and actually had a lower annual women’s health care–related costs than women who were dispensed 3 cycles.12
We recently presented data that support this conclusion—hormonal method continuation rates were higher among women who received 3 pill packs than in those who received only 1. Having the supply of pills available is one more way of promoting contraceptive success.
Are there side effects that are specific to the extended regimen OCs?
DR SULAK: We are in consensus that there are no side effects that are specific to the extended regimen OCs. The only side effect found to be increased with extended regimen is unscheduled bleeding, but some studies have shown less bleeding overall.13 Studies have shown a decrease in many typical side effects seen with 21/7 OCs such as premenstrual syndrome and headaches.14
DR KAUNITZ: I agree. We should, however, address unscheduled bleeding and spotting. It’s something that we see with every OC, but extending the regimen changes the pattern.
A number of years ago, a randomized trial showed that addition of low-dose estrogen to the HFI provided superior cycle control to that of a 20-mcg EE OC and similar to that reported with a 35-mcg pill.15 There are more recent data that suggest that once you have passed the first cycle, addition of low-dose estrogen to the HFI also improves unscheduled bleeding in 91-day regimens.6
MS MOORE: Patients must understand there will be some unscheduled bleeding/spotting as their endometrium transitions from a monthly cycle or withdrawal bleed to more complete ovarian suppression, but it is manageable.
DR LONDON: Some clinicians have concerns about estrogen exposure—specifically the risk of venous thromboembolism and breast cancer. When the published data regarding extended regimens are examined in total, the safety profile is virtually the same as for 21/7. The safety of 91-day regimens have been demonstrated in both 1-year trials as well as longer-term 2-year studies.2,6,16
The Women’s CARE (Contraceptive and Reproductive Experiences) study really put concerns about the association of OC use and breast cancer to rest.17 There was no evidence of increased risk of breast cancer in either current or past users of OCs. Given that the study included women who had taken high-dose 50-mcg EE pills, it’s very reasonable to conclude that extended OC use poses no increased risk of breast cancer.
What can be done to ensure that an extended regimen is offered to all OC-appropriate patients regardless of age or pathology?
DR KAUNITZ: We still need to work on overcoming common misconceptions. Despite more than 45 years of use, a fundamental lack of understanding of how OCs work persists among patients and health care professionals outside the field of women’s health.
MS MOORE: Many of my students are incredulous when they realize that there is no physiologic reason for the 7-day HFI and cyclical bleeding for women taking OCs.
DR LONDON: We also need to dispel the myth that women taking OCs are having periods. Remember that no women taking an OC has a period. They have withdrawal bleeding.
DR SULAK: Extended regimens set my patients up for contraceptive success and should be considered for all women who are candidates for OCs. The advantages—avoidance of monthly withdrawal symptoms, less follicular development, and, overall, less bleeding—outweigh the issues of unscheduled bleeding and spotting.
DR NELSON: We should discuss bleeding with our patients and, perhaps, it is time to turn the tables and ask her why she feels the need to bleed every month. For women considering use of OCs, it opens up the conversation to use of regimens other than 21/7. For women who are established users of OCs, asking whether they are having symptoms every month will open up the same conversation.
DR KAUNITZ: We’re not here to suggest that women should no longer menstruate or that women should no longer experience monthly bleeding.
It’s all about choice. Using hormones not only to provide safe, effective contraception but also to allow women the option of choosing when to bleed is a second revolution in contraception.
With regard to symptoms, I ask about grouchiness. “Do you get headaches or feel grouchy or down during your HFI?” If the answer is yes, it moves the conversation in the direction of extended regimens.